The scientific research enterprise, like other human activities, is built on a foundation of trust. Scientists trust that the results reported by others are valid. Society trusts that the results of research reflect an honest attempt by scientists to describe the world accurately and without bias. The level of trust that has characterized science and its relationship with society has contributed to a period of unparalleled scientific productivity. But this trust will endure only if the scientific community devotes itself to exemplifying and transmitting the values associated with ethical scientific conduct.

National Academy of Sciences, On Being a Scientist (1995) http://www.nap.edu/readingroom/books/obas/preface.html

Accepted practices for the responsible conduct of research can and do vary from discipline to discipline and even from laboratory to laboratory. There are, however, some important shared values for the responsible conduct of research that bind all researchers together, such as:

HONESTY — conveying information truthfully and honoring commitments ACCURACY — reporting research findings precisely and taking care to avoid errors EFFICIENCY — using resources wisely and avoiding waste

OBJECTIVITY— letting the facts speak for themselves and avoiding improper bias¹⁰

Versiti relies on all Research Staff Members to establish and maintain the highest standards of ethical practices in research and provides both formal and informal training. Each individual Research Staff Member is expected to:

Versiti staff and non-Versiti personnel who know or suspect that a Versiti staff member has engaged in Research Misconduct are strongly encouraged to immediately Report such circumstances to the Versiti Executive Vice President of Research or the Compliance Officer. Individuals may also Report concerns to Versiti’s third-party compliance hotline provider (refer to Versiti’s Whistleblower Policy for contact information). Complainants are encouraged to provide as much information and documentation as possible, including any presentations, publications, or other documents that may be affected by the alleged misconduct.

The EVP of Research will take all reasonable and practical steps to protect the positions and reputations of good faith Complainants, Respondents, witnesses and committee members who participate in the review process.¹¹ All Versiti representatives are strictly prohibited from engaging in any form of retaliation against any individual (or entity) who: (i) communicates a good faith concern related to Research Misconduct (regardless of whether such concern reflects actual wrongdoing); or (ii) cooperates in any Inquiry or Investigation regarding such concern. Prohibited retaliatory behavior includes any negative action that would deter a reasonable person in the same situation from communicating or participating in the Investigation of a concern related to Versiti practices or conduct. Examples of retaliatory behavior include, but are not limited to, discharging, demoting, suspending, threatening, harassing, disciplining, changing a job or shift assignment, or in any other manner discriminating or retaliating against any person or entity involved in the good faith communication or Investigation of a concern. Versiti Personnel who engage in Retaliatory Behavior in violation of this Policy will be subject to disciplinary action, up to and including termination. The EVP of Research will undertake all reasonable and practical efforts, if requested and as appropriate, to protect or restore the reputation of persons alleged to have engaged in Research Misconduct, but against whom no finding of Research Misconduct is made.¹²

To the maximum extent possible given legal requirements and the need to conduct effective Research Misconduct Proceedings, the identity of Respondents, Complainants, research subjects, and others who participate in Research Misconduct proceedings will be kept confidential.¹³

This Policy is also intended to protect individuals against false allegations of Research Misconduct. Any communication that proves to be both unsubstantiated and made with malice or with knowledge of its falsity is not protected by this Policy. Versiti Personnel who (i) knowingly or with reckless disregard for the truth give false information, (ii) knowingly make a false Report of wrongful conduct, or (iii) knowingly submit a false Report of retaliation, will be subject to disciplinary action, up to and including termination. As stated in Section 3.2 above, allegations that are not substantiated, yet are made in good faith, are not subject to corrective action or any form of retaliation.

The EVP of Research will notify the Office of Research Integrity and if applicable, the funding agency (i.e. NIH) immediately if he/she has reason to believe that any of the following special circumstances exist:¹⁴

The EVP of Research will:

The EVP of Research will notify the Office of Research Integrity if Versiti plans to close a case at the Inquiry or Investigation stage on the basis that the Respondent has admitted guilt, a settlement with the Respondent has been reached, or for any other reason, except the closing of a case at the Inquiry stage on the basis that an Investigation is not warranted.¹⁷

The EVP of Research will file annual compliance Reports with the Office of Research Integrity.¹⁸

Within one (1) week of his/her receipt of allegation(s), the EVP of Research, in consultation with the Chief Executive Officer and the Compliance Officer, will assess the allegation(s) to determine whether an Inquiry is warranted. An Inquiry is warranted if: (1) the allegation(s), if true, would constitute Research Misconduct; and (2) the allegations are sufficiently credible and specific so that potential evidence of Research Misconduct may be identified.¹⁹ The EVP of Research’s findings at the conclusion of the preliminary assessment will be summarized in a Preliminary Assessment Report. If the EVP of Research determines that an Inquiry is warranted, the EVP of Research will notify the Chief Executive Officer and the Inquiry process will proceed as described in Section 6.

The EVP of Research will promptly take all reasonable and practical steps to obtain custody of all Research Records and evidence needed to conduct Research Misconduct Proceedings. The EVP of Research shall inventory the Research Records and evidence, and sequester them in a secure manner.²⁰ If there are Research Records or other evidence that encompass scientific instruments shared by a number of users, custody may be limited to copies of the data or evidence on such instruments, so long as those copies are substantially equivalent to the evidentiary value of the instruments.²¹ Whenever possible, the EVP of Research will take custody of the Research Records: (1) before or at the time the EVP of Research notifies the Respondent of the allegations, Inquiry or Investigation; and (2) whenever additional documentation becomes known or relevant.²²

If appropriate, the EVP of Research will give the Respondent copies of, or reasonable supervised access to, the Research Records.²³

The destruction, absence of, or Respondent’s failure to provide research records adequately documenting the questioned research is evidence of Research Misconduct if a preponderance of the evidence indicates that:

If the EVP of Research determines that an Inquiry is warranted, the Inquiry process must be completed within sixty (60) calendar days of the Inquiry Initiation Date, unless circumstances clearly warrant a longer period. The Inquiry initiation date shall be the date upon which notice of the Inquiry is sent to the Respondent (the “Inquiry Initiation Date”). If the Inquiry takes longer than sixty (60) days to complete, the Inquiry record will include documentation of the reasons for exceeding the 60-day period.²⁵

On or before the date upon which the Respondent is notified of the Inquiry, the EVP of Research will promptly take all reasonable and practical steps to obtain custody of all the Research Records and other evidence needed to conduct Research Misconduct Proceedings. See Section 5.2.

The EVP of Research will appoint an Inquiry Committee. The Inquiry Committee shall include at least three (3) members who do not have real or apparent conflicts of interest in the case, are unbiased, and have the necessary expertise to evaluate the evidence and issues related to the allegations, interview the principals and key witnesses, and conduct the Inquiry. Inquiry Committee Members may be scientists, subject matter experts, administrators, lawyers, or other qualified persons, and they may be from inside or outside Versiti. Non-Versiti Inquiry Committee Members will be required to sign conflict of interest and confidentiality statements prior to serving on the Inquiry Committee. The Inquiry Committee may consult with outside legal counsel as necessary.

The EVP of Research will provide the Respondent with written notice of the pending Inquiry, before or at the time of Inquiry initiation. The written notice will include: (1) of the nature of the allegations; (2) the composition of the Inquiry Committee; (3) a copy of this Policy; and (4) a copy of the applicable federal regulations (42 CFR Part 93).²⁶ If the Respondent objects to the participation of any Inquiry Committee member based upon allegations of bias or conflict of interest, the Respondent will inform the EVP of Research of such objections in writing within five (5) business days of the Respondent’s receipt of the Inquiry notice. The EVP of Research will determine if the Respondent’s objections have merit and replace any challenged member with a qualified substitute, if necessary. If the inquiry subsequently identifies additional Respondents, Versiti must notify them.

The Inquiry Committee shall conduct the Inquiry by examining available evidence and interviewing the Complainant, Respondent, key witnesses (the Inquiry Committee will record or transcribe all interviews). The purpose of the Inquiry is not to reach a final conclusion about whether misconduct definitely occurred or who was responsible; therefore, a full review of all of the evidence is not required.²⁷ The purpose of the Inquiry is to make a preliminary evaluation of the available evidence and testimony of the Respondent, Complainant, and key witnesses to determine whether there is sufficient evidence of possible Research Misconduct to warrant a formal Investigation.

An Investigation is warranted if: (1) there is a reasonable basis for concluding that the allegation falls within the definition of Research Misconduct; and (2) preliminary information-gathering and preliminary fact-finding from the Inquiry process indicates that the allegation may have substance.²⁸ The Inquiry Committee will prepare an Inquiry Report (see Section 7)

Within thirty (30) days of the Inquiry Initiation Date, the Inquiry Committee will prepare a draft written Inquiry Report that includes all of the following information:

The EVP of Research will provide the Respondent with a copy of the draft Inquiry Report for review and comment.³⁰ The Complainant may also be provided relevant portions of the draft Inquiry Report for comment. If any Complainant wishes to remain anonymous, their names will be redacted from the copy of the draft Inquiry Report provided to the Respondent. The Respondent and Complainant must provide his/her comments to the draft Inquiry Report (if any) to the Inquiry Committee within five (5) business days of his/her receipt of the draft Inquiry Report.³¹

Any comments that the Respondent or Complainant submits on the draft Inquiry Report will become part of the Final Inquiry Report and record. Based on the comments, the Inquiry Committee may revise the draft Report as appropriate. The Inquiry Committee will prepare a written Final Inquiry Report that includes all of elements identified in Section 7.1 and comments to the Report by the Respondent and Complainant.

If the Inquiry Committee determines that an Investigation is warranted, the Investigation must begin within thirty (30) days of the date upon which the EVP of Research provided the Respondent with written notice of the Investigation.³⁴ All aspects of the Investigation must be completed within 120 days of beginning the Investigation, including conducting the Investigation, preparing the final Investigation Report, and sending the final Report to ORI.³⁵ If Versiti is unable to complete the an Investigation related to PHS-funded research in 120 days, the EVP of Research must ask ORI for an extension in writing.³⁶ If ORI grants an extension, it may direct the EVP of Research to file periodic progress Reports.³⁷

To the extent the EVP of Research has not already done so at the allegation or Inquiry stages, the EVP of Research shall take all reasonable and practical steps to obtain custody of, inventory, and sequester Research Records and other evidence as provided in Section 5 above.

The EVP of Research, in consultation with the Chief Executive Officer and the Compliance Officer, will appoint an Investigation Committee and a Committee Chair. The Investigation Committee will consist of at least three individuals who do not have real or apparent conflicts of interest in the case, are unbiased, and have the necessary expertise to evaluate the evidence and issues related to the allegations, interview the principals and key witnesses, and conduct the Investigation. These individuals may be scientists, administrators, subject matter experts, lawyers, or other qualified persons, and they may be from inside or outside Versiti. Individuals appointed to the Investigation Committee may also have served on the Inquiry Committee. Members of the Investigation committee will be required to sign conflict of interest and confidentiality statements prior to serving on the Investigation committee.

Within a reasonable amount of time after determining that an Investigation is warranted, but before the Investigation begins, the EVP of Research will provide the Respondent with written notice of the pending Investigation. The written notice will include: (1) a description of the allegations (including any new allegations); (2) the composition of the Investigation Committee; (d) a statement that a copy of this Policy and the applicable federal regulations (42 CFR Part 93) were provided in the Inquiry notice, but are available upon request.³⁸ If the Respondent objects to the participation of any Investigation Committee member based upon allegations of bias or conflict of interest, the Respondent will inform the EVP of Research of such objections in writing within five (5) business days of the Respondent’s receipt of the Investigation notice. The EVP of Research will determine if the Respondent’s objections have merit and replace any challenged member with a qualified substitute, if necessary.

The Investigation Committee will prepare a draft Investigation Report that describes:⁴⁶

The Investigation Committee will consider and address the comments to the draft Investigation Report made by the Respondent and/or Complainant (if any) before issuing the final Investigation Report.⁴⁸ The Investigation Committee will prepare a final Investigation Report that includes all of elements identified in Section 9.1 and comments to the Report by the Respondent and/or Complainant (if any).

The EVP of Research and the Corporate Compliance Committee will review this Policy every two years. Questions regarding the implementation of this Policy should be directed to Versiti’s EVP of Research or Corporate Counsel/Compliance Officer.

Versiti will make this Policy available to all Versiti Research Staff on its Internet. New Versiti Research Staff Members will complete a training session that addresses the content of this Policy. Thereafter, Versiti Research Staff Members will repeat the required training: (1) at least every four (4) years; and (2) if and when Versiti materially revises this Policy.⁵¹

A finding of Research Misconduct and/or failure to comply with the provisions of this Policy may result in discipline, up to an including termination of employment.